Five-year outcomes of the ICEBERG study, an international, prospective, multicenter registry on the GORE® EXCLUDER® Iliac Branch Endoprosthesis for aorto-iliac aneurysms.
Daphne van der Veen, Suzanne Holewijn, Raffaello Bellosta, Luca Attisani, Steven M M van Sterkenburg, Jan M M Heyligers, Ilaria Ficarelli, Francisco J Gómez Palonés, Nicola Mangialardi, Nilo J Mosquera, Andrew Holden, Michel M P J Reijnen
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引用次数: 0
Abstract
Objective: This study aims to provide insight in the long-term outcomes of patients treated with the Gore Excluder Iliac Branch Endoprosthesis (IBE) for aneurysms involving the common iliac artery. Both technical, clinical, and patient reported outcomes were evaluated.
Methods: This is an investigator initiated, international, real world post-market, multicenter, prospective cohort study, enrolling patients with an indication for elective treatment of an (aorto)iliac aneurysm using the Gore Excluder IBE. Technical and clinical outcomes were collected through 5-year follow-up, together with questionnaire data.
Results: Of the initially 100 enrolled patients, 69 patients completed the 5-year follow-up. The 5-year freedom from all-cause and aneurysm-related mortality was, respectively, 82.9% and 96.0%. The 5-year primary patency of the hypogastric artery was 84.0%. The median abdominal aortic aneurysm and common iliac artery diameters decreased significantly between baseline and 5-year follow-up (-8.0mm, p=0.001, -6.8mm, p<0.001, respectively). One type 1b and one type 1c endoleak were detected between 2-5 years follow-up which were successfully treated. Two type III endoleaks were discovered during follow-up. There were no significant differences in the occurrence nor severity of intermittent claudication between baseline and 5-year follow-up. The outcomes on the IIEF-5 questionnaire on erectile dysfunction showed a significant decrease between baseline (median 12.5; IQR 3.0-20.0) and 5-years follow-up (median 4.0; IQR 1.0-16.0), p=0.001. The EQ5D and WIQ showed no differences between baseline and 5-years follow-up.
Conclusions: The results of this study support the continued use of the Gore Excluder IBE in the treatment of aortoiliac aneurysms, demonstrating favorable long-term outcomes in terms of patency, sac remodeling, clinical outcomes and questionnaire outcomes.
期刊介绍：
Journal of Vascular Surgery ® aims to be the premier international journal of medical, endovascular and surgical care of vascular diseases. It is dedicated to the science and art of vascular surgery and aims to improve the management of patients with vascular diseases by publishing relevant papers that report important medical advances, test new hypotheses, and address current controversies. To acheive this goal, the Journal will publish original clinical and laboratory studies, and reports and papers that comment on the social, economic, ethical, legal, and political factors, which relate to these aims. As the official publication of The Society for Vascular Surgery, the Journal will publish, after peer review, selected papers presented at the annual meeting of this organization and affiliated vascular societies, as well as original articles from members and non-members.
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